1-month vs 12-month DAPT for ACS Patients Who Underwent PCI Stratified by IVUS: IVUS-ACS and ULTIMATE-DAPT Trials

N/AActive Not RecruitingNCT03971500

Nanjing First Hospital, Nanjing Medical University3,710 enrolled

Overview

Prospective, multicenter, randomized, double-blind, placebo-controlled trials.

A total of 3486 subjects with ACS who met inclusion criteria and do not have any exclusion criterion will be randomized to IVUS- or Angiography-guidance group (first randomization). In the IVUS-guidance group, IVUS will be used to evaluate the lesion's specificity and to measure lesion length, landing zone, and reference vessel diameter prior-to stenting; and to assess stent expansion, extension, apposition, and possible complications after stent implantation. The IVUS- defined criteria for the optimal stent deployment included: 1) the minimal stent area (MSA) in the stented segment is \>5.0 mm\^2, or 90% of the MLA at the distal reference segments; 2) plaque burden 5-mm proximal or distal to the stent edge is \<55%; and 3) absence of \>Type B edge dissection. Further treatment will be required if stenting procedure is defined as suboptimal according to IVUS definition. IVUS will be not allowed to be used in the Angiography-guidance group. Those patients who have had no death, STEMI, stroke, ST, TVR or major bleeding (BARC 3 or 5) within 30 days and have continued on aspirin and ticagrelor for 30 days without interruption for \>48 hours will be randomized 1:1 to: 1. Ticagrelor plus+ matching placebo for an additional 11 months (SAPT group) 2. Ticagrelor plus aspirin (study drug) for an additional 11 months (DAPT group) Follow-up of all subjects will continue for 1 year with an option for additional follow-up to 3 years.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

3,710

Conditions

Coronary Artery Disease

Interventions

AntiPlatelet therapyDRUG

AntiPlatelet therapy with ticagrelor + aspirin or ticagrelor alone.

Percutaneous coronary interventionPROCEDURE

PCI with DES implantation

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: Enrollment into the study will require meeting at least one of these clinical syndromes within 1 month. * Unstable angina, defined as rest pain for 5-30 minutes or deteriorative exertional angina with either a) transient ST segment depression or elevation, or b) angiography showing a visually estimated diameter stenosis ≥90% or a ruptured plaque or thrombotic lesion * Non-ST elevation myocardial infarction (NSTEMI), defined as positive troponin consistent with clinical syndrome. * ST elevation MI (STEMI) Exclusion Criteria: * Unable or unwilling to provide informed consent * Stroke within 3 months or any permanent neurologic deficit, and prior intracranial bleed, or any intracranial disease such as aneurysm or fistula * Previous coronary artery bypass graft (CABG) * Any planned surgery within 90 days * Any reason why any antiplatelet therapy might need to be discontinued within 12 months * Severe chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m\^2 * Need for chronic oral anticoagulation (warfarin/coumadin or direct oral anticoagulants) * Platelet count \< 100,000 mm\^3 * Contraindication to aspirin * Contraindication to ticagrelor * Liver cirrhosis * Women of child-bearing potential * Life expectancy \< 1 year * Any condition likely to interfere with study processes including medication compliance or follow-up visits (e.g. dementia, alcohol abuse, severe frailty, long distance to travel for follow-up visits, etc.)

Locations (1)

Nanjing First Hospital

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Target vessel failure (TVF)

The difference in TVF will be calculated from 0 month to 12 months between IVUS- and Angiography guidance groups.

Time frame: 12 months

Clinically-relevant bleeding

The difference in clinically-relevant bleeding (BARC ≥2) will be calculated from 1 month to 12 months between SAPT and DAPT groups.

Time frame: 11 months

Major adverse cardiovascular and cerebrovascular events (MACCE)

The difference in MACCE will be calculated from 1 month to 12 months between SAPT and DAPT groups.

Time frame: 11 months

Secondary Outcomes

Net adverse clinical events (NACE)

The difference in NACE between IVUS- and Angiography guidance groups, or SAPT and DAPT groups.

Time frame: 12 months

Data from ClinicalTrials.gov

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